Zai Lab's bemarituzumab study shows attenuated survival benefit

Zai Lab Limited announced the completion of the final analysis for the Phase 3 FORTITUDE-101 trial of bemarituzumab, in partnership with Amgen. The study evaluated bemarituzumab in combination with chemotherapy (mFOLFOX6) for first-line gastric cancer.

While an interim analysis initially showed a clinically and statistically significant improvement in overall survival, the final analysis revealed an attenuation in the magnitude of this benefit. Amgen plans to present both sets of results at an upcoming major medical meeting.

Following these updated results, Zai Lab will await the outcomes of the FORTITUDE-102 trial before proceeding with regulatory filings. FORTITUDE-102 is evaluating bemarituzumab combined with nivolumab and chemotherapy in the same patient population, with data anticipated by the end of 2025 or the first half of 2026.